Flurbiprofen Axetil for Uterine Contraction Pain | NCT00725218

Studies
Flurbiprofen Axetil for Uterine Contraction Pain

NCT00725218

Sponsor

Nanjing Medical University

Status

Completed

Last Update Posted

Aug 6, 2008Estimated

Enrollment

97Actual

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

Saline
Flurbiprofen Axetil

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
M089732

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jul 28, 2008

First Submission Date that Met QC Criteria

Jul 28, 2008

First Posted Date

Jul 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2008

Last Update Posted Date

Aug 6, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Uterine contraction pain is a common problem after abortion. Optimal analgesic for such suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of prostaglandin E (PGE). The investigators hypothesized that Flurbiprofen Axetil could suppress the uterine contraction pain after abortion effectively.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Saline 5 ml injection 10 min prior to propofol administration.	Drug: Saline
2	Experimental	Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.	Drug: Flurbiprofen Axetil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Saline	Drug	Saline 5 ml injection 10 min prior to propofol administration.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS pain scorings		At the end of the operation, 0,5,15,30,60min after operation

Secondary Outcomes

Measure	Description	Time Frame
Anesthetic consumptions		At the end of the operation
Overall VAS satisfaction scorings with analgesia		At the end of the study
Side effects

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA status I-II
Performing abortion operation (medical- or drug-induced
Requiring painless abortion

Exclusion Criteria:

< 19yrs, and >= 45yrs
History of central active drugs administration
Drug abuse
Hypertension
Diabetes
Any other chronic diseases
Allergy to the study drugs
Habit of over-volume alcohol drinking
Records of history of centrally active drug use and psychiatry
Any organic disorders

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
XiaoFeng Shen, MD	Nanjing Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing Maternal and Child Health Care Hospital		Nanjing	Jiangsu	210004	China

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D000377	Agnosia

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride
D000077331	Ringer's Solution
C504422	flurbiprofen axetil

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided